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Completed

NCT Number: NCT04560361

The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia

The investigators designed the multicenter randomized parallel controlled clinical trial of electroacupuncture on PHN which is rigorously designed and have an appropriate sample size, aiming to evaluate the efficacy and safety of electroacupuncture in pain relieving and pain removing in the treatment of patients with PHN.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huai'an Hospital of Traditional Chinese Medicine, Huai'an, Jiangsu, China

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About this study

Postherpetic neuralgia(PHN) is the most common complication of herpes zoster, is a severe and intractable pain with a high incidence. Nearly 50% of PHN patients have experienced persistent pain for more than one year. Although it is not directly life-threatening, will lead to sleep disorders, even depression, seriously affecting the quality of life of patients. This project is a multi-center randomized controlled trial, which will recruit 448 patients with PHN in 7 hospitals, aiming to evaluate the analgesic effect and safety of electroacupuncture on postherpetic neuralgia, and provide evidence-based medical evidence for electroacupuncture treatment of PHN.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who meet the diagnostic criteria for postherpetic neuralgia (with a clear history of acute herpes zoster, and the duration of postherpetic pain exceeds 90 days)
  • Aged 45 to 75 years old
  • Patients who were diagnosed with moderate or above pain during the observation period (the daily pain score was continuously collected within 7 days during the observation period, and the average NRS-11 pain score was >=4)
  • Subjects who did not participate in other ongoing clinical studies
  • Sign informed consent and volunteer to participate in the study

Exclusion criteria

  • Patients who are currently receiving or receiving more than one of the "permitted combinations" or any "prohibited combination and treatment" for PHN listed in the following part at least 14 days before screening, and are unwilling to undergo washout period, or patients with serious safety problems during washout period or observation period
  • Patients who are expected to receive any new prescription drug or other treatment for PHN after the start of the trial
  • Patients with serious uncontrolled medical conditions, such as cardiovascular, lung, liver, kidney, gastrointestinal tract, metabolism, endocrine, nervous system, respiratory system, urogenital system and other serious diseases, or systemic organ dysfunction, malignant tumor, hematologic disease such as bleeding tendency or coagulation dysfunction, serious mental illness such as depression or schizophrenia Symptoms, hepatitis B antigen or hepatitis C antibody positive known state or history of immune dysfunction, history of HIV infection, etc.
  • Patients with severe pain unrelated to PHN, such as after surgery for clinical major diseases
  • Patients with PHN who have received nerve intervention or other neurosurgical treatment, such as selective nerve damage, percutaneous radiofrequency thermocoagulation or pulsed nerve modulation technology, etc.
  • Patients with some special types of herpes zoster, such as those with meninges, cornea, conjunctiva, ear involvement, visceral herpes zoster, generalized herpes zoster
  • Patients with skin ulceration, new herpes, or skin infection
  • Patients with cardiac pacemaker, metal allergy or severe fear of needle
  • Patients who are unable to give full informed consent or cannot cooperate with pain scale assessment due to mental, mental, linguistic or behavioral disorders
  • Patients who have poor compliance or are prone to fall off due to other reasons, such as the current residence is not in the city where the recruitment hospital is located, or the working environment changes frequently
  • Pregnant and lactating women

Treatment and study plan

Electroacupuncture treatment

Other

Continue the electroacupuncture treatment as described above for 30 minutes.

Sham electroacupuncture treatment

Other

Continue the sham electroacupuncture treatment as described above for 30 minutes.

Primary outcomes

  1. Change in pain intensity (NRS-11)

    Time frame: Change from Baseline at 4 weeks after treatment

    11-point numeric rating scale (NRS-11): range from 0 (no pain) to 10 (worst possible pain), with 1-3 points representing mild pain, 4-6 points representing moderate pain, and 7-10 points representing severe pain. A reduction of ≥30% in NRS-11 scores from baseline were considered responders.

Secondary outcomes

  1. Change in pain intensity (VAS)

    Time frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment

    Visual analogue scale (VAS): a horizontal line without verbal descriptors or numbers at intermediate points (0=no pain, 10=worst imaginable pain)

  2. Change in the interference of pain on sleep

    Time frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment

    Verbal rating scale (VRS): 4 levels.

    • Level 0: No pain.
    • Level I (mild): Pain but tolerable, normal life, no interference with sleep.
    • Level II (moderate): Pain is obvious, unbearable, requires analgesic medication, and sleep is disturbed.
    • Level III: Severe pain, unbearable, analgesic medication, severe interference with sleep, accompanied by autonomic dysfunction or passive positions.
  3. Change in mechanical pain threshold (MPT)

    Time frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment

    Stimulated the most painful central part of PHN with a series of von Frey hairs (0.008-300 g).

  4. Change in pain area of PHN (PAP)

    Time frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment

    calculated by the researcher based on 45 body areas rating scale (BARS-45) which requires the use of height and weight of the patient.

  5. Change in average number of pain episodes per day

    Time frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment

    Painless: 0 times; Intermittent pain: 1-50 times (1-2, 3-5, 6-10, 11-50 optional); Persistent pain: >50 times.

  6. Change in average duration of each pain episode (ADEPE)

    Time frame: Change from Baseline at 1 day, 3 days, 1 week, 2 weeks, 3 weeks and 4 weeks after treatment

    Duration ranges from 0 minutes (no pain) to 24 hours (persistent pain).

  7. Change in the nature and intensity of pain

    Time frame: Change from Baseline at 4 weeks after treatment

    short form of McGill pain questionnaire 2 (SF-MPQ-2): includes 22 items.

  8. Change in degree of pain and its impact on work life, interpersonal relationships and sleep

    Time frame: Change from Baseline at 4 weeks after treatment

    Zoster brief pain inventory (ZBPI)

  9. Change in depression, anxiety and positive outlook scale (DAPOS)

    Time frame: Change from Baseline at 4 weeks after treatment

    11 items, combines depression (5 items), anxiety (3 items) and positive outlook (3 items).

  10. Change in overall impression of PHN

    Time frame: 4 weeks

    Patient global impression of change (PGIC): Participants were asked to describe their overall impression of change of their condition/pain by answering the following question: "Compared to your pain at admission to the project, how much has it changed?" (categories: much improved = 1, mildly improved = 2, unchanged = 3, mildly worsened = 4, much worsened = 5).

Sponsors and collaborators

Lead sponsor

Nanjing University of Traditional Chinese Medicine

Other

Registry information

Official study title

The Analgesic Effect of Electroacupuncture on Postherpetic Neuralgia: a Multicenter Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2020
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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